Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002351
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
A Study of L-735524 in HIV-Positive Children and Adolescents
Sponsor:
Merck Sharp Dohme LLC
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
An Open-Labeled Multiple Dose Multicenter Study to Investigate the Safety Tolerability and Plasma Concentration Profile of L-735524 Capsules in HIV-Seropositive Older Children and Adolescent Patients
Status:
COMPLETED
Status Verified Date:
1995-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To evaluate the safety tolerability and plasma concentration profiles of indinavir sulfate MK-639 Crixivan in HIV-seropositive older children and adolescents To compare the plasma concentration profile after the initial dose with data from a historical group of adults To obtain preliminary data on antiviral activity of MK-639
Detailed Description:
Patients receive MK-639 for 14 and one-third days Repeat plasma samples are collected up to 8 hours following the first and last dose Urine samples are collected on days 1 and 5
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 026-01 | None | None | None |